Direct-To-Consumer Ads: Manufacturers Face ‘Cease And Desist’ Orders Now, Uncertain Future, Pink Sheet

Morgan Lewis partner Maarika Kimbrell is quoted in a Citeline article that article reports on the FDA’s issuance of targeted cease-and-desist letters asking pharmaceutical manufacturers to stop allegedly false or misleading direct-to-consumer advertising amid an uncertain regulatory and enforcement landscape.

“I think the standard that FDA would like to hold industry to is also somewhat unclear at this juncture,” she said. “Formally the rules have not changed. The statute hasn’t changed. The regulations have not changed. But clearly they want industry to react to the announcements that they made [on Sept. 9] and exactly how to do that when you don’t know where the lines are, it’s hard to know that you’re coloring within them.”

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